Data-Backed Celltrion Looks To File Xolair Biosimilar ‘This Year’
Bumper Year Planned, With Up To Five Filings On Company’s Agenda
Likely frontrunner Celltrion has published 24-week Phase III data for its CT-P39 biosimilar Xolair candidate, which tees up a planned biosimilar filing later this year.
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New Jersey-based biosimilar and 505(b)(2) specialist Kashiv Biosciences is in the race with multiple Xolair biosimilar sponsors, including frontrunner Celltrion.
Celltrion has become the latest firm to reveal that it has filed a biosimilar Eylea application with the US FDA in the form of its CT-P42 aflibercept candidate.
Celltrion is keeping both eyes firmly on the future as it begins clinical trials for one biosimilar and files another in Europe.